Trial Condition(s):

Diabetes Mellitus

Prevention of postprandial hyperglycemia by acarbose may be a promising therapeutic strategy for reducing the increased risk for cardiovascular disease (ABDOMEN)

Bayer Identifier:

13066

ClinicalTrials.gov Identifier:

NCT01167231

EudraCT Number:

Not Available

Study Completed

Trial Purpose

The use of acarbose in impaired glucose tolerance (IGT) and type 2 diabetic subjects has been associated with a significant reduction of cardiovascular events. Additionally, acarbose has been shown to have a beneficial influence on some of the other cardiovascular risk factors (metabolic syndrome components). Thus, prevention of postprandial hyperglycemia by acarbose may be a promising therapeutic strategy for reducing the increased risk for cardiovascular disease. Further studies are needed to confirm the influence of acarbose on cardiovascular risk factors in the real life setting.

Inclusion Criteria
- Diabetes Mellitus
 - Age >/= 18 years
 - Naive to acarbose (minimum 3 months before inclusion)
Exclusion Criteria
- Hypersensitivity to acarbose or any of the excipients
 - Age <18 years
 - Pregnancy and in nursing 
 - Inflammatory bowel disease, colonic ulceration, partial intestinal obstruction or in patients predisposed to intestinal obstruction
 - Chronic intestinal diseases associated with marked disorders of digestion or absorption
 - States which may deteriorate as a result of increased gas formation in the intestine, (e.g. Roemheld’s syndrome [an angina pectoris-like syndrome or aggravation of an angina pectoris due to the postprandial filling of the stomach] and larger hernias) 
 - Hepatic and severe renal impairment (creatinine clearance <25 mL/min/ 1,73m2)

Trial Summary

Enrollment Goal
3310
Trial Dates
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Phase
N/A
Could I receive a placebo?
No
Products
Acarbose (Precose/Glucobay, BAYG5421)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

Many Locations, Poland

Status
Completed
 

Trial Design